Clinical Utility of the Numerical Verbal Scale (NVS) and the Pain and Functional Activity Scale (PFAS) in the Management of Rescue Analgesia in Acute Postoperative Pain. Randomized Study.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacin Biomedica Galicia Sur

About this trial

Adequate postoperative pain management, along with mobilization and early oral nutrition, is the foundation for optimal recovery after surgery.

Unidimensional pain scales (Numerical Verbal Rating Scale - NRS, Visual Analogue Scale - VAS, Categorical Scale - CRS, Facial Pain Scale - FPS) do not adequately reflect a patient's actual analgesic needs. Basing analgesic treatment on the classic algorithm of administering opioids if pain is greater than 4 on the NRS, without considering functional impairment, has been shown to be a cause of overtreatment in surgical wards.

The Functional Activity Score (FAS) is the simplest scale, designed for bedside application and geared toward therapeutic decision-making. R: Able to perform any activity; B: Pain prevents some activity; C: Unable to perform any activity.

Given the need to standardize functional limitation when measuring postoperative pain, we propose the Pain and Functional Activity Scale (PFAS), which combines the NVA (Non-Visual Analogue Scale) with the Functional Activity Scale. Specifically, pain on movement would be recorded using the NVA in motion (NVAm), along with functional limitation (A, B, or C). The rescue analgesia treatment algorithm adapted to the PFAS would involve treating patients with pain greater than 4 on the NVA whenever it represents a severe limitation of their functional activity (C).

In this study, we aim to evaluate whether there are significant differences in the proportion of patients who meet the criteria for needing rescue analgesia according to the NVA compared to the proportion of patients who meet the criteria for needing rescue analgesia established by the PFAS, during the 2-day postoperative period.

To this end, an experimental, longitudinal, prospective, randomized, single-blind study for the data analyzer will be carried out, where a group that will receive rescue analgesia if VNS\>4 and another if VNSm\>4 + FAS C will be compared in the first two days of postoperative surgical patients of the surgeries selected in the EOXI of Vigo.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Scheduled surgery with VATS admission

Age > 18 years

Signed informed consent

Disqualifiers

Cognitive-mental deficit assessed using the Pfeiffer questionnaire. Patients with more than two errors if they have a university degree and more than three errors if they do not have a university degree are excluded from the study.

Allergy to any of the analgesic drugs listed on the data collection sheet (Paracetamol / NSAIDs / Metamizole / Dexamethasone / Local anesthetics / Morphine / Fentanyl).

Patients who, in the preoperative survey, present any degree of functional limitation according to the FAS scale (Grade B and C).

If the patient withdraws consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group A: Rescue analgesia if NVS>4

    Procedure/Surgery

    Rescue analgesia will be self-administered by the patient, when post-surgical pain is moderate to severe, using morphine PCA at a dose of 0.075 mg/kg maximum every 15 minutes, up to a maximum of 3 times per hour, provided they meet the criteria described for the group to which they have been assigned.

  • Group B: Rescue analgesia if NVSm > 4 + FAS C

    Procedure/Surgery

    Rescue analgesia will be self-administered by the patient, when post-surgical pain is moderate to severe and this pain interferes with and limits functional activity, using morphine PCA at a dose of 0.075 mg/kg maximum every 15 minutes, up to a maximum of 3 times per hour, provided they meet the criteria described for the group to which they have been assigned.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

NVS

Resting Numerical Verbal Scale (NVS), indicate one of the following options (0 = no pain 10 = the worst pain imaginable): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10.

Time frame
Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.
2

mNVS

Moving Numerical Verbal Scale (mNVS), indicate one of the following options (0 = no pain 10 = the worst pain imaginable): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10.

Time frame
Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.
3

FAS

Functional Activity Score (FAS): After evaluating the following activities: Sitting, Walking, Rehabilitation, Respiratory Physiotherapy; indicate how pain interferes with your functional activity and rank them from best to worst: * A: Able to perform any activity (performs all 4 activities without limitation) * B: Pain prevents some activity (unable to perform between 1 and 3 of the activities) * C: Unable to perform any activity (is unable to perform any of the activities)

Time frame
Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.

Secondary outcomes

1

Age

Patient age in years

Time frame
Day 0 (before the surgical intervention)
2

Gender

Patient gender (Female, Male)

Time frame
Day 0 (before the surgical intervention)
3

BMI

Patient body mass index

Time frame
Day 0 (before the surgical intervention)
4

Pfeiffer

Cognitive-mental deficit assessed according to the Pfeiffer questionnaire: 1\. What is today's date (day, month, year)? 2. What day of the week is it today? 3. Where are we now (place or building)? 4. What is your telephone number? (or your address if you don't have a telephone) 5. How old are you? 6. What is your birth year? 7. Who is the current Prime Minister? 8. Who was the previous Prime Minister? 9. What is your mother's second surname? 10. Subtract 3 each time from the number 20. Patients with more than 2 errors if they have a university degree and more than 3 errors if they do not have a university degree will be excluded from the study. After completing the questionnaire, the variable is recorded as yes/no.

Time frame
Day 0 (before the surgical intervention)

Other outcomes

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